Software Quality Assurance Supervisor jobs in Waukesha, WI

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 
 

The Quality Assurance Supervisor will be knowledgeable in industry regulations, industry best practices, and phase appropriate quality systems. This role must be quality focused and understand cGMP manufacturing and the associated quality systems. The QA Supervisor is responsible for oversight of quality operations activities. In this capacity, the incumbent can perform the final disposition of executed batch records, approve quality departures (i.e. unplanned deviations, CAPA's, temporary change controls), and approve procedures. Additional responsibilities may include representing Quality Assurance in operations meetings, project meetings, client meetings, and inspections. The Quality Assurance Supervisor must be highly organized demonstrating excellent communication skills and may organize/delegate workload among Quality Assurance personnel.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. 
 

We proudly offer

•   Generous benefit options (eligible first day of employment) 
•   Paid training, vacation and holidays (vacation accrual begins on first day of employment)
•   Career advancement opportunities 
•   Education reimbursement
•   401k program
•   Learning platform
•   And more! 
 

*** This position has supervisory responsibilities ***

Duties

1. Work cross-functionally with Manufacturing, Process Engineering, Facility, Inspection and Project Management on Quality Assurance (QA) activities such as the following:
   1. Review Executed/Unexecuted Batch Record
   2. Oversee and implement on-floor QA
   3. Review Executed/Unexecuted Validation/Facility Protocols/Reports
   4. Investigate and write documentation for Unplanned Deviations, Planned Deviations, Environmental Monitoring Excursions and Equipment Excursions
   5. Review incoming materials/components
   6. Author, review and revise SOPs
   7. Review Change Controls
2. Coordinate with the QA Management and Operations to ensure disposition timelines and Quality KPIs are attained
3. Coordinate with the QA Management to ensure client timelines are on schedule and attainable
4. Work in coordination with QA Management to ensure QA staffs are appropriately trained and procedures are being followed
5. Perform QA visual inspection activities associated with clinical and commercial drug product
6. Support validation activities including cleaning, validating process and equipment, reviewing validation documentation and recommending methods to increase the quality of products and/or services.
7. Assist in assuming responsibility for the Curia compilation of documentation, systems and controls, to ensure inspection-ready quality systems (FDA, QP, EMEA) for domestic and international inspections and registrations
8. Participate in client calls
9. Participate in regulatory and client audits
10. Train and mentor team members
11. Write, review, and approve Annual Product Reviews
12. Review and approve stability protocols and reports
13. Support quality functions outside of quality operations as needed

Required

• Bachelor’s degree in Life Science or related field 
• 5-8 years’ experience of pharmaceutical/biotechnology or medical device industry experience, including a minimum 5 years’ experience in Quality Assurance

Preferred

• Former supervisory experience
• Experience in the review of validation (process, IOPQ) protocols and reports

Knowledge, Skills & Abilities: 

1. Excellent written and verbal presentation and communication skills
2. Strong problem-solving skills, with the ability to resolve conflict
3. Knowledge in FDA, cGMPs (21 CFR, 210/211, 820, and ICH Q7) Ability to effectively present information to management and/or peers
4. Comfortable working independently in combination with individuals in other departments across the organization

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to handle or feel. The employee is occasionally required to stand, walk, reach with hands and arms; climb or balance and stoop, kneel, crouch.

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; and risk of radiation and vibration. The noise level in the work environment is usually moderate.”

Pay Range:

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.  

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